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Phase II Study of Dehydroepiandrosterone in Androgen Receptor-Positive Metastatic Breast Cancer

Elisabetta Pietri1, Ilaria Massa2, Sara Bravaccini3

  • 1Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.

The Oncologist
|December 29, 2018
PubMed
Abstract

Insights

Dehydroepiandrosterone (DHEA) combined with aromatase inhibitors showed good safety but limited effectiveness in treating metastatic breast cancer. High variability in DHEA levels may hinder its future development for this condition.

Area of Science:

  • Oncology
  • Endocrinology
  • Pharmacology

Background:

  • Androgen receptors (AR) are prevalent in breast cancer (BC), yet therapeutic targeting remains challenging.
  • AR-agonists demonstrate some efficacy in BC treatment.
  • Dehydroepiandrosterone (DHEA), an androgen precursor, was investigated for its potential in AR-positive metastatic breast cancer (MBC).

Purpose of the Study:

  • To evaluate the safety and activity of DHEA in combination with an aromatase inhibitor (AI) for AR-positive MBC.
  • To assess the clinical benefit rate in patients with estrogen receptor (ER)-positive and triple-negative MBC.
  • To explore the role of DHEA as a therapeutic agent in advanced breast cancer.

Main Methods:

  • A two-stage phase II clinical study was conducted.
  • Patients received oral DHEA (100 mg/day) along with an AI to inhibit estrogen conversion.
  • Two cohorts were enrolled: ER-positive (AI-resistant) and triple-negative MBC; the triple-negative cohort was terminated early.

Main Results:

  • Twelve patients with ER-positive MBC were enrolled; DHEA was well-tolerated with manageable adverse events.
  • One patient with ER-positive disease and AR gene amplification achieved clinical benefit.
  • Significant inter- and intra-patient variability in serum DHEA and metabolite levels was observed.

Conclusions:

  • DHEA demonstrated excellent safety but poor clinical activity in metastatic breast cancer.
  • While dose optimization and patient selection might be considered, the high variability in serum DHEA levels presents a significant challenge for its further development in this context.
  • The study suggests limited efficacy of the DHEA and AI combination in AR-positive MBC.

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